This application claims a priority based on Japanese Patent Application No.2000-381529 filed on Dec. 15, 2000 and No. 2001-221182 filed on Jul. 23, 2001, the entire contents of which are incorporated herein by reference for all purposes.
1. Field of the Invention
The present invention relates to improvements in therapeutic material delivery device (vehicle) for delivering (implanting) a therapeutic material such as a coiled or capsulated radioactive source to an organism for radiotherapy, for example, of a patient suffering prostate cancer.
2. Description of the Related Art
Radiotherapy (brachytherapy) refers to a treatment made by allowing a radioactive beam to radiate to a morbid tissue suffering a prostate cancer, an esophagus cancer, or the like. Radiotherapy includes high-dose, external beam radiation treatment and low-dose close-distance radiation treatment.
It is present practice to employ the latter method as a method for improving a therapeutical effect depending upon a therapeutic site and reducing side effects. In this case, there is practiced a method in which a radioactive source having radioactivity in the form of a sealed radioactive source is implanted (caused to remain) in a diseased part or a part near a morbid part with a delivery needle for the radioactive source, to treat the diseased part. The present invention is applied to the above method using the sealed radioactive source. The radioactive source for use in the present invention is selected from those containing radioactive isotopes that are clinically utilizable, and examples thereof include isotopes of cobalt, phosphorus, strontium, cesium, palladium, yttrium, iridium, rhenium, etc. Particularly preferred are isotopes that radiate xcex2 rays.
The above delivery needle is constituted of an inner needle member having a tubular needle and an outer needle member having a sticking needle formed to have a sharpened forward end, and a plurality of the capsular radioactive sources having radioactivity and having a size of approximately 5 mm are charged into the above outer needle member with tweezers. The above radioactive sources are spaced with spacers formed of a biodegradable substance, and a wax is applied to the forward end of the above sticking needle, so that the above radioactive sources do not come off the sticking needle.
When capsular radioactive sources are implanted in a diseased part with a delivery needle having the above sticking needle, approximately five radioactive sources are charged into one sticking needle as described above and are linearly implanted in the diseased part. In this manner, approximately 25 sticking needles above (corresponding to 125 radioactive sources) are embedded in different implantation positions. In the implantation, the implantation positions are secured while monitoring the positions with an ultrasonic diagnosis apparatus, so that the diseased part is uniformly irradiated with the radioactive sources.
Coiled radioactive sources formed by coiling rod-like or wire-like radioactive sources are recently used in place of capsular radioactive sources. That is because the coiled radioactive sources have a large surface area each and the length of the radioactive sources per piece can be increased as compared with the capsular radioactive sources, so that the number of the radioactive sources required can be decreased. The coiled radioactive sources are therefore less frequently charged into the outer needle member as compared with the capsular radioactive sources. Further, there is the merit of being free from spots that are not irradiated with a radioactive ray (cold spots), since it is not required to insert the spacers.
However, when a conventional inner needle member having a tubular needle and a conventional outer needle member having a sticking needle, which are used for implanting capsular radioactive sources, are used for implanting coiled radioactive sources in a diseased part, the coiled radioactive sources come to be curved, so that the irradiation with a uniform dose of radioactive ray can be no longer possible.
It is therefore required to prepare a medical sticking needle having a three-layered structure formed of an inner needle member through which coiled radioactive sources are to be passed or generally an inner needle member for holding a therapeutic material such as radioactive sources and extruding them forward, a middle needle member for fixing the radioactive sources and an outer needle member that is to be inserted into a diseased part or an intended portion, that is, a therapeutic material delivery device. The present invention relates to improvements in the above delivery device for delivering a therapeutic material such as radioactive sources.
Further, the delivery device may be a therapeutic material delivery device that is formed of an inner needle member for holding a therapeutic material such as radioactive sources and extruding them forward, a cartridge chargeable with the therapeutic material and an outer needle member that is to be inserted into a diseased part or an intended portion. The present invention also relates to improvements in such a delivery device using said cartridge.
It is an object of the present invention to provide a protective tool for a therapeutic material delivery device, which is for preventing wrong or accidental sticking of the outer needle after use and for preventing dissipation of blood adhering to the outer needle, and a delivery device having the tool.
It is another object of the present invention to provide a cartridge for use with a therapeutic material delivery device, which cartridge permits direct calibration of a radioactive source charged therein, and a delivery device having the cartridge.
It is still another object of the present invention to provide a cartridge for use with a therapeutic material delivery device, which cartridge is free from easy breakage of a connector tube connected to an outer needle of the delivery device, and a delivery device having the cartridge.
It is yet another object of the present invention to provide a cartridge for a therapeutic material delivery device, which cartridge permits extrusion of charged radioactive sources to the forward end of an outer needle without any resistance, and a delivery device having the cartridge.
It is further another object of the present invention to provide a cartridge for use with a therapeutic material delivery device, which cartridge permits calibration of the length of radioactive sources charged therein by easy external reading, and a delivery device having the cartridge.
Still further other objects of the present invention will be clear by descriptions to be made hereinafter.
According to the present invention, (1) there is provided a protective tool 68A or 68B for a therapeutic material delivery device comprising an outer needle 2 having an outer tubular needle 2A and an outer needle hub 2B supporting the outer tubular needle 2A, the protective tool being to be attached to said outer needle 2 for the protection thereof,
the protective tool comprising a cover 8xe2x80x2A and a cap 61 or stopper 65 attached to a forward end of said cover for protecting the forward end of the outer tubular needle 2A,
wherein said cover 8xe2x80x2A is formed of a plurality of tubes 8xe2x80x2A1, 8xe2x80x2A2, 8xe2x80x2A3, . . . having different diameters that are formed so as to consecutively decrease from a forward place to the outer needle hub 2B in a backward place, and said tubes are thereby connected such that the cover 8xe2x80x2A is extendable in the longitudinal direction.
According to the present invention, further, (2) there is provided a protective tool 68A for a therapeutic material delivery device as recited in the above (1), wherein said cap 61 has an inner tube 61A formed inside, said inner tube 61A has, made in a bottom thereof, a hole 62 for inserting and passing said outer tubular needle 2A, and said inner tube 61A has, formed in an outer circumference, a groove portion 63 for inserting a forward end of said outer tubular needle.
According to the present invention, further, (3) there is provided a protective tool 68B for a therapeutic material delivery device as recited in (1), wherein said stopper 65 is constituted of a tubular opening/closing portion 66 having a forward end and a connector portion 70,
said opening/closing portion 66 has slits 71 formed in the longitudinal direction, one in an upper portion and the other in a lower portion, said forward end has an opening portion 66a, and said connector portion 70 has pressing portions 67 formed, one on the right and the other on the left, and has cutout grooves 69 formed, one in an upper place and the other in a lower place.
According to the present invention, further, (4) there is provided a protective tool 68A or 68B for a therapeutic material delivery device comprising an outer needle 2 having an outer tubular needle 2A and an outer needle hub 2B supporting the outer tubular needle 2A, a middle needle 3 having a middle tubular needle 3A and a middle needle hub 3B supporting the middle tubular needle 3A and an inner needle 4 having a solid needle 4A and an inner needle hub 4B supporting the solid needle 4A, the outer needle, the middle needle and the inner needle being to be connected for use, the protective tool being to be attached to said outer needle 2 for the protection thereof,
which protective tool comprises a cover 8xe2x80x2A and a cap 61 or a stopper 65 that is attached to the forward end of said cover for protecting the forward end of said outer tubular needle 2A,
wherein said cover 8xe2x80x2A is formed of a plurality of tubes 8xe2x80x2A1, 8xe2x80x2A2, 8xe2x80x2A3, . . . having different diameters that are formed so as to consecutively decrease from a forward place to the outer needle hub 2B in a backward place, and said tubes are thereby connected such that the cover 8xe2x80x2A is extendable in the longitudinal direction.
According to the present invention, further, (5) there is provided a protective tool 68A for a therapeutic material delivery device as recited in (4), wherein said cap 61 has an inner tube 61A formed inside, said inner tube has, in a bottom thereof, a hole 62 for inserting and passing said outer tubular needle 2A, and said inner tube 61A has, formed in an outer circumference thereof, a groove portion for inserting the forward end of said outer tubular needle 2A.
According to the present invention, further, (6) there is provided a protective tool 68B for a therapeutic material delivery device as recited in (4), wherein said stopper 65 is constituted of a tubular opening/closing portion 66 having a forward end and a connector portion 70,
said opening/closing portion 66 has slits 71 formed in the longitudinal direction, one in an upper portion and the other in a lower portion, said forward end has an opening portion 66a, and said connector portion 70 has pressing portions 67 formed, one on the right and the other on the left, and has cutout grooves 69 formed, one in an upper place and the other in a lower place.
According to the present invention, further, (7) there is provided a therapeutic material delivery device 1A or 1B comprising an outer needle 2 having an outer tubular needle 2A and an outer needle hub 2B supporting the outer tubular needle 2A, wherein said outer needle 2 is covered with the protective tool 68A or 68B for a therapeutic material delivery device as recited in any one of (1) to (3), and the forward end of said outer tubular need 2A of said outer needle 2 is capped with a sheath 5xe2x80x2 for protecting said forward end.
According to the present invention, further, (8) there is provided a therapeutic material delivery device 1A or 1B as recited in (7) wherein said sheath 5xe2x80x2 has a projection 6xe2x80x2 formed on an inner-circumference base portion thereof.
According to the present invention, further, (9) there is provided a therapeutic material delivery device 1A or 1B comprising an outer needle 2 having an outer tubular needle 2A and an outer needle hub 2B supporting the outer tubular needle 2A, a middle needle 3 having a middle tubular needle 3A and a middle needle hub 3B supporting the middle tubular needle 3A and an inner needle 4 having a solid needle 4A and an inner needle hub 4B supporting the solid needle 4A, said outer needle 2, said middle needle 3 and said inner needle 4 being to be connected in this order for use,
wherein the protective tool 68A or 68B for a therapeutic material delivery device as recited in any one of (4) to (6) is attached to said outer needle 2.
According to the present invention, further, (10) there is provided a therapeutic material delivery device 1A or 1B as recited in (9), wherein said solid needle 4A is inserted in said middle tubular needle 3A, said middle tubular needle 3A is inserted in said outer tubular needle 2A and the forward end of said outer tubular needle 2A is capped with a sheath 5xe2x80x2 for protection of said forward end.
According to the present invention, further, (11), there is provided a therapeutic material delivery device 1A or 1B as recited in (9) or (10), wherein said outer tubular needle 2A, said middle tubular needle 3A and said solid needle 4A are formed such that said solid needle 4A has a largest length, that said middle tubular needle 3A has an intermediate length and that said outer tubular needle 2A has a smallest length.
According to the present invention, further, (12) there is provided a therapeutic material delivery device 1A or 1B comprising a outer needle 2 having an outer tubular needle 2A and an outer needle hub 2B supporting the outer tubular needle 2A, a middle needle 3 having a middle tubular needle 3A and a middle needle hub 3B supporting the middle tubular needle 3A and an inner needle 4 having a solid needle 4A and an inner needle hub 4B supporting the solid needle 4A,
wherein said outer needle 2, said middle needle 3 and said inner needle 4 are being to be connected for use.
According to the present invention, further, (13) there is provided a therapeutic material delivery device 1A or 1B as recited in (12), wherein the forward end of the outer tubular needle 2A of said outer needle 2 is capped with a sheath 5xe2x80x2 for protection of said forward end.
According to the present invention, further, (14) there is provided a therapeutic material delivery device 1A or 1B as recited in (13), wherein said sheath 5xe2x80x2 has a projection 6xe2x80x2 formed on an inner circumference base portion thereof.
According to the present invention, further, (15) there is provided a therapeutic material delivery device 1A or 1B as recited in (12), wherein said outer tubular needle 2A, said middle tubular needle 3A and said solid needle 4A are formed such that said solid needle 4A has a largest length, that said middle tubular needle 3A has an intermediate length and that said outer tubular needle 2A has a smallest length.
According to the present invention, further, (16) there is provided a cartridge 7, 17 or 37 for a therapeutic material delivery device, which cartridge permits external visual observation of the therapeutic material, the cartridge comprising a transparent cartridge body 8, 18 or 38 that holds said therapeutic material 10 inside and permits external visual observation of the therapeutic material 10 and a shielding outer tube 9, 19 or 39 that is fitted on an outer circumference of the cartridge body, is slidable in the longitudinal direction of said cartridge body and is made of a radioactive ray shielding material, said cartridge body 8, 18 or 38 being exposable with said sliding of said shielding outer tube.
According to the present invention, further, (17) there is provided a cartridge 7 or 17 for a therapeutic material delivery device as recited in (16), wherein the forward end of said cartridge body 8 or 18 is provided with a head portion 5 or 5A, a connector tube 6 is supported through said head portion, and said connector tube 6 is capped with a sheath 12 having an opening portion 12A formed therein.
According to the present invention, further, (18) there is provided a cartridge 37 for a therapeutic material delivery device as recited in (16), wherein the forward end of said cartridge body 38 is provided with a head portion 5E, a connector tube 36 is supported through said head portion and said connector tube 36 is capped with a cap C1 having a protection portion 21 and a spindle rod 22 supported on a central portion of inner circumference end portion of the protection portion 21.
According to the present invention, further, (19) there is provided a cartridge 7 or 37 for a therapeutic material delivery device as recited in any one of (16) to (18), wherein an engagement portion 5C or 35C is formed in the backward end of the head portion 5 or 5E provided in the forward end of said cartridge 7 or 37, an engagement portion 9A or 38A is formed in the forward end of said outer tube 9 or 39, and these engagement portions are engageable with each other.
According to the present invention, further, (20) there is provided a cartridge 7, 17 or 37 for a therapeutic material delivery device as recited in any one of (16) to (19), wherein a stopper 16 is attached to nearly a central portion of said head portion 5, 5A or 5E of said cartridge body 8, 18 or 38, and said cartridge body and said outer tube are engageable with each other on the basis of a frictional resistance between said stopper 16 and an inner circumference of forward end of said outer tube 9, 19 or 39.
According to the present invention, further, (21) there is provided a cartridge 7 or 17 for a therapeutic material delivery device as recited in any one of (16), (17), (19) and (20), wherein an outer circumference surface of said cartridge body 8 or 18 is provided with a scale 20 for checking a length or an amount of the therapeutic material 10 charged inside said cartridge body 8 or 18.
According to the present invention, further, (22) there is provided a cartridge 37 for a therapeutic material delivery device as recited in any one of (16), (18), (19) and (20), wherein an outer circumference surface of said cartridge body 38 is provided with a scale 30 having divisions starting at 0 cm at intervals of 1 cm for checking a length of the therapeutic material 10 charged in said cartridge body 38 and for calibration of the entire therapeutic material 10.
According to the present invention, further, (23) there is provided a cartridge 27 for a therapeutic material delivery device, which cartridge has a cartridge body 28 that permits external visual observation of a therapeutic material 10 held therein, wherein said cartridge body 28 is formed of material that can work as a shield against radioactive rays and has a scale 20 provided on an outer circumference of said cartridge body 28, the forward end of said cartridge body 28 has a head portion 5B, a connector tube 6 is supported through said head portion, and said connector tube 6 is capped with a sheath 12 having an opening portion 12A formed therein.
According to the present invention, further, (24) there is provided a therapeutic material delivery device 1 comprising an outer needle 2 or 32 having an outer tubular needle 2A or 32A and an outer needle hub 2B or 32B supporting the outer tubular needle 2A or 32A, the cartridge 7, 17, 27, 37 for a therapeutic material delivery device as recited in any one of (16) to (23) which cartridge is chargeable with a therapeutic material 10 and an inner needle 4 having a solid needle 4A and an inner needle hub 4B supporting the solid needle 4A,
wherein an inner circumference of said outer needle hub 2B or 32B and the forward end portion of said cartridge 7, 17, 27 or 37 are formed to have mutually engageable forms,
the therapeutic material delivery device 1 having a constitution in which said solid needle 4A is inserted through the backward end of said cartridge 7, 17, 27 or 37 thereby to extrude said therapeutic material 10 into said tubular needle 2A or 32A with the forward end of said solid needle 4A.